What do Annex I Part A and Part B mean instead of Annex IV?
The Machinery Regulation replaces the former Annex IV of the Machinery Directive with a two-part Annex I. Part A lists machinery for which a notified body always has to be involved. For Part B, internal production control is only permitted where the harmonised standards are applied in full; otherwise a notified body is required as well.
What is the difference between Part A and Part B?
| Annex I Part A | Annex I Part B | |
|---|---|---|
| Notified body | Always mandatory | Only where harmonised standards are not applied in full |
| Internal production control | Not permitted | Permitted where standards are applied in full |
| Typical content | Machinery with self-evolving behaviour based on machine learning, safety components with such behaviour | Classic high-risk machinery from the former Annex IV scope |
| Consequence for planning | Plan firmly for external assessment, allow for lead time and cost | Demonstrate application of standards without gaps, otherwise the procedure changes |
The specific classification of individual machine types follows from the text of the regulation. Check the current version before deciding on a conformity assessment procedure.
What changes compared with Annex IV of the Machinery Directive?
Under Machinery Directive 2006/42/EC, Annex IV contained a fixed list of machinery categories. For these, internal production control was possible where harmonised standards were applied in full; otherwise a notified body had to be involved.
The Machinery Regulation splits this logic. For Part A the choice disappears entirely: a notified body is always required, regardless of the application of standards. For Part B the previous system remains.
The second key difference: the list is dynamic. It can be adapted by delegated act without amending the regulation as a whole.
What does the dynamic annex mean for my planning?
Until now the Annex IV list was effectively stable over the lifetime of the directive. Under the Machinery Regulation, Annex I can change while your machine is already in development.
The practical consequence: checking whether your machine is listed does not belong only at the start of the project but again shortly before placing it on the market. In long-running special purpose machinery projects the classification can change between order and delivery.
Different dates circulate for the first adaptation. The text of the regulation names a review duty by 20 July 2028; alongside that a date of 20 July 2026 is mentioned. Check this point against the current status in the Official Journal before making binding statements to customers.
How do I determine the right procedure for my machine?
What does applying harmonised standards in full mean?
It means applying the relevant harmonised standards without cutting corners: not only in part, not merely in a similar spirit, and without deviations of your own on safety-related provisions.
This is where a practical trap lies. If no matching type-C standard exists for your design and you derive safety from EN ISO 12100 and the type-B standards, you are not applying the harmonised standards in full in the sense of the presumption of conformity. For a machine under Annex I Part B that can force the route via a notified body.
For new designs without a matching type-C standard, such as cube-based storage systems with container robots, you should clarify this point early. It determines the schedule and the cost of the conformity assessment procedure.
Sources and standards
- Machinery Regulation (EU) 2023/1230, Annex I Parts A and B
- Machinery Directive 2006/42/EC, Annex IV (valid until 19 January 2027)
- BAuA: information on the Machinery Regulation
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Frequently asked questions
Does Annex IV still apply after 20 January 2027?
No. From 20 January 2027 only Machinery Regulation (EU) 2023/1230 with its Annex I applies. Parallel application of the Machinery Directive and the Machinery Regulation is not provided for.
Does machinery with AI functions always need a notified body?
Not across the board. Annex I Part A covers machinery and safety components with fully or partly self-evolving behaviour based on machine learning that concerns safety functions. AI functions unrelated to safety do not trigger it; the distinction has to be drawn cleanly in the documentation.
What does involving a notified body cost?
That depends on the machine type, the procedure and the scope of assessment and cannot be quoted flatly. Besides the fees, allow above all for lead time. Assessment slots are scarce and demand is likely to rise towards the deadline.
Do I have to do anything for existing machinery?
No. What counts is the moment of placing on the market. Machinery lawfully placed on the market before 20 January 2027 keeps its legal status and does not have to be reassessed afterwards.
Has been guiding CE projects in machinery, plant and special purpose engineering for years. That work led to Kaidoc.app, a software for standards-based CE documentation. Through Knutec.de the same work is available as a personal service.
Write me a few lines about your project. You get a first assessment back, free of charge and without obligation.
This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
No credit card required. A complete project to try out.